Get Tweaked, LLC
Quality Metrolgy and Validation

Validation Terms

 Validation (drug manufacture), documenting that a process or system meets its pre-determined specifications and quality attributes

Verification and validation, in engineering,` confirming that a product or service meets the needs of its users


  • Design qualification (DQ)- Demonstrates that the proposed design (or the existing design for an off-the-shelf item) will satisfy all the requirements that are defined and detailed in the User Requirements Specification (URS). Satisfactory execution of the DQ is a mandatory requirement before construction (or procurement) of the new design can be authorised.
  • Installation qualification (IQ) – Demonstrates that the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.
  • Operational qualification (OQ) – Demonstrates that all facets of the process or equipment are operating correctly.
  • Performance qualification (PQ) – Demonstrates that the process or equipment performs as intended in a consistent manner over time.
  • Validation Subsections


  • Cleaning validation
  • Process validation
  • Analytical method validation
  • Computer system validation

    Qualifying Subsections

  • Design qualification] (DQ)
  • Component qualification (CQ)
  • Installation qualification (IQ)
  • Operational qualification (OQ)
  • Performance qualification (PQ)